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ClinicalTrials.gov Identifier: NCT00136370

Recruitment Status
: Unknown

Verified September 2007 by Centers for Disease Control and Prevention. Recruitment status was: Recruiting

The purpose of this study is to evaluate whether use of the disinfectant chlorhexidine administered to the birth canal during labour and newborn at delivery can protect a woman and her baby from bacterial infections after birth. If effective, this could be used as an inexpensive alternative to antibiotics to prevent newborn infections in resource-poor countries.

We are conducting a randomized, controlled clinical trial in Soweto, South Africa to evaluate the efficacy of 0.5% chlorhexidine wipes of the birth canal during labour and of the infant at birth in reducing 1) vertical transmission of leading pathogenic bacteria from mother to child during labour and delivery, and 2) incidence of neonatal sepsis and maternal peripartum infection, in comparison to external genitalia sterile water wipes. In conjunction with this, we will compare vaginal carriage of bacteria commonly associated with neonatal sepsis and maternal peripartum infection among HIV-infected and non-infected pregnant women who deliver at the only public hospital in Soweto, and will characterize the burden of disease and risk factors for maternal peripartum infection and serious neonatal infections in this population by conducting active prospective surveillance.

Preventing Serious Neonatal and Maternal Peripartum Infections in Developing Country Settings With a High Prevalence of HIV Infection: Assessment of the Disease Burden and Evaluation of an Affordable Intervention in Soweto, South Africa

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Ages Eligible for Study:

15 Years and older (Child, Adult, Senior)

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Criteria

Inclusion Criteria:

Pregnant

Plan to deliver at Chris Hani Baragwanath Hospital or one of its satellite clinics

Plan to remain in Soweto for at least two months after delivery

Are able to understand and give informed consent

Are at least 15 years old at time of registration

Exclusion Criteria:

Planned delivery by caesarean section

Antenatal ultrasound revealing major fetal congenital anomalies

Have known or suspected condition in which vaginal exams are contraindicated, e.g. placenta previa

Have a history of allergic reaction to any topical antiseptic solution

Present to labour ward with infant born before arrival

Present to labour ward with significant vaginal bleeding during labour

Present with known intrauterine fetal death prior to randomization

Subject noted to be in full cervical dilatation or have baby's head on perineum